Capricor Therapeutics Faces Investor Lawsuit Deadline Amid Regulatory Setback

Investors seeking to lead a securities class action against Capricor Therapeutics must file their motions by September 15. This legal development follows a significant regulatory setback for the biotechnology company’s lead therapeutic candidate, Deramiocel. Despite a notable single-day surge of 13.5% that pushed shares to $6.74 on Friday, the stock continues to demonstrate extreme price volatility.

The catalyst for current investor actions occurred on July 11, when the U.S. Food and Drug Administration issued a Complete Response Letter rejecting Deramiocel’s approval application. Regulators cited insufficient evidence of effectiveness and requested additional clinical data to support the submission. Particular concerns were raised regarding chemistry, manufacturing, and controls (CMC) issues.

Market reaction to this regulatory decision was immediate and severe. Share prices Read more...